Welcome to our dedicated page for Neurocrine Biosciences news (Ticker: NBIX), a resource for investors and traders seeking the latest updates and insights on Neurocrine Biosciences stock.
Neurocrine Biosciences Inc (Nasdaq: NBIX) is a neuroscience-focused biopharmaceutical company whose news flow centers on clinical data, product performance and pipeline progress in movement disorders, neuropsychiatry, endocrinology and metabolic disease. The company regularly issues updates on its flagship VMAT2 inhibitor INGREZZA (valbenazine) for tardive dyskinesia and chorea associated with Huntington’s disease, including head-to-head pharmacologic studies, long-term efficacy analyses and peer-reviewed publications.
NBIX news commonly features clinical trial readouts across its pipeline. Recent releases have covered Phase 3 and Phase 4 data for INGREZZA in tardive dyskinesia and Huntington’s disease chorea, a Phase 3 study of valbenazine in dyskinetic cerebral palsy, and Phase 2 results for investigational compounds such as NBI-1070770 in major depressive disorder. Investors and clinicians can also follow updates on late-stage programs including osavampator for major depressive disorder and direclidine for schizophrenia and bipolar mania, as well as next-generation VMAT2 inhibitors and CRF-based therapies for metabolic diseases like obesity.
Another major theme in Neurocrine Biosciences news is financial and corporate reporting. The company announces quarterly net product sales for INGREZZA and CRENESSITY, provides guidance ranges for research and development and selling, general and administrative expenses, and discusses its R&D strategy at events such as its annual R&D Day and healthcare investor conferences. Management presentations at large industry meetings, including the J.P. Morgan Healthcare Conference and other investor conferences, are also highlighted in press releases.
This NBIX news page aggregates these updates so readers can quickly review earnings announcements, clinical milestones, R&D strategy briefings, investor conference appearances and key scientific publications related to Neurocrine Biosciences. For anyone tracking developments in tardive dyskinesia, Huntington’s disease chorea, classic congenital adrenal hyperplasia, neuropsychiatric disorders or emerging CRF-based metabolic therapies, the news stream provides a concise view of the company’s ongoing activities and disclosures.
Neurocrine Biosciences announced that CEO Kevin Gorman will retire on October 11, 2024, and will be succeeded by Kyle Gano, the current Chief Business Development and Strategy Officer. Gano will also join the Board of Directors. Gorman, who founded the company in 1992, will remain on the Board. Under Gorman's leadership, Neurocrine has evolved into a fully integrated biopharmaceutical company with a robust pipeline and strong financial performance. Key achievements include the launch of INGREZZA and recent FDA submissions for crinecerfont. Neurocrine now has 17 clinical programs and aims to advance its mission in neurology, neuroendocrinology, and neuropsychology.
Neurocrine Biosciences announced the presentation of new Phase 3 CAHtalyst™ data at ENDO 2024, focusing on congenital adrenal hyperplasia (CAH) in both adults and children. The data includes results from randomized, double-blind, placebo-controlled trials evaluating crinecerfont's efficacy, safety, and tolerability. Additional presentations cover modified-release hydrocortisone (MRHC) studies for primary adrenal insufficiency and CAH, analyzing the impact of supraphysiologic glucocorticoid dosing and disease-related comorbidities. These findings have supported New Drug Application submissions to the FDA in April 2024.
The presentations will take place from June 1-4 in Boston, featuring key data and several posters highlighting the company's neuroendocrinology pipeline.
Neurocrine Biosciences announced the publication of a post hoc analysis from the Phase 3 KINECT-4 study on INGREZZA (valbenazine) capsules in the Journal of Clinical Psychopharmacology. The analysis assessed long-term outcomes for tardive dyskinesia (TD) and showed significant, sustained improvements in symptom severity over 48 weeks.
Highlights include a 55% improvement in symptoms by Week 4 on the starting dose, rising to 95% by Week 24, and 97% by Week 48. The study involved 103 participants who showed a mean AIMS score reduction of 10.5 by Week 48.
Overall, 86% of participants achieved at least a 50% improvement, with 52% reaching a 70% improvement threshold. Patient and healthcare professional ratings indicated over 88% of participants showed 'much' or 'very much' improved symptoms. INGREZZA was generally well-tolerated over the study period.
Neurocrine Biosciences, along with Diurnal, presented data from their CAHtalyst™ Phase 3 studies and CHAMPAIN Phase 2 study at the European Congress of Endocrinology 2024. The CAHtalyst studies focused on congenital adrenal hyperplasia (CAH) in children and adults, revealing limitations in current treatments. Despite high doses of glucocorticoids, participants showed elevated adrenal androgen levels and comorbidities like obesity and advanced bone age.
CHAMPAIN Phase 2 study of modified-release hydrocortisone (MRHC) in adults with primary adrenal insufficiency showed that 45 out of 49 participants achieved physiological morning cortisol levels after four weeks, compared to only 2 on Plenadren.
The Phase 3 extension study of MRHC in CAH patients demonstrated a reduction in median daily hydrocortisone dose and an increase in responders achieving targeted hormone levels.
These findings highlight the potential of MRHC in improving hormonal control and reducing glucocorticoid use in CAH and adrenal insufficiency patients.
Neurocrine Biosciences presented data from the CAHtalyst™ Adult Study, highlighting the need for new treatment options in congenital adrenal hyperplasia (CAH) patients. Baseline characteristics revealed the long-term consequences of current treatments, with patients experiencing disorders typically found in older individuals. A literature review showed an increased risk of psychiatric and cognitive symptoms in CAH patients receiving high glucocorticoid doses. These findings were presented at the AACE 2024 Annual Meeting.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has initiated a Phase 1 clinical study for the investigational compound NBI-1076986 targeting movement disorders. The study aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. This compound, an M4 subtype-selective muscarinic acetylcholine receptor antagonist, shows promise for treating conditions like Parkinson's disease tremor and dystonia.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has initiated a Phase 1 clinical study for NBI-1117567, an oral muscarinic agonist, to evaluate its safety and efficacy in healthy adults. The compound aims to treat neurological and neuropsychiatric conditions, potentially improving cognition in patients with psychosis.
Neurocrine Biosciences, Inc. (NBIX) will present at the BofA Securities 2024 Health Care Conference, featuring top executives discussing the company's commitment to developing life-changing treatments for neurological disorders. The conference will be webcasted live and a replay will be available on the company's website. Neurocrine Biosciences has a strong portfolio of FDA-approved treatments and a robust pipeline in late-stage development.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present key information at the European Congress of Endocrinology 2024, including baseline characteristics data from CAHtalyst™ Program of crinecerfont in CAH, and data from modified-release hydrocortisone studies in primary adrenal insufficiency and CAH. The presentations will cover pediatric and adult baseline characteristics data in congenital adrenal hyperplasia, Phase 2 Clinical Study Data for Modified-Release Hydrocortisone, Phase 3 Extension Study Data for Modified-Release Hydrocortisone in CAH, and more.
Neurocrine Biosciences, Inc. (NBIX) supports Tardive Dyskinesia Awareness Week to advocate for routine screening and monitoring of TD, a movement disorder caused by antipsychotic medication affecting approximately 600,000 people in the U.S. annually.